Randomized Study on Bilateral Versus Standard Mediastinal Lymphadenectomy in Patients With Lung Cancer-Early Results and Safety Analysis.

OBJECTIVES: To evaluate whether bilateral mediastinal lymphadenectomy (BML) affects the feasibility and invasiveness of lung resection in patients with lung cancer and its associated risks of adverse effects (AE). METHODS: This multicentre randomized trial compared BML and systematic lymph node dissection (SLND). In all patients, standard anatomical lung resection was performed. In the BML group, the contralateral mediastinum was additionally dissected using the cervical approach. RESULTS: In total, 279 patients (135 BML and 144 SLND) were eligible for analysis; both groups had comparable basic clinical parameters. Both groups were comparable in terms of resection type (P = 0.193), blood loss (P = 0.927), and number of AE (P = 0.289). Compared with the SLND group, the BML group had a longer duration of surgery (440 minutes vs 133 minutes, P < 0.001) and a greater number of removed lymph nodes (45 vs 21, P < 0.001). Both groups were comparable in terms of AE (P = 0.171) and severe AE (P = 0.179). In the BML group, chest drainage duration and air leak duration were longer (8.3 vs 4.5 days, P < 0.001 and 1.9 vs 1.5 days, P = 0.026, respectively), the total volume of chest tube discharge was larger (1573 vs 907 mL, P < 0.001), and pain intensity on each of the 5 postoperative days was higher (P < 0.001). CONCLUSIONS: BML during pulmonary resection in patients with lung cancer is feasible and does not increase the risk of complications. It enables significantly more extensive lymphadenectomy but is associated with a longer duration of surgery and increased air leak duration, chest tube drainage, and pain intensity.